510(k) K180432
K180432 is an FDA 510(k) premarket notification submitted by Shenzhen Carewell Electronics., Ltd. for the device "AI-ECG Platform". The FDA issued a decision of Substantially Equivalent on Nov 19, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 2018
- Date Received
- Feb 20, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)